Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05744193
Status:
TERMINATED
Last Update Posted:
2024-07-09
First Post:
2023-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feeding Study in VLBW Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': 'Daily for 28 days', 'description': 'grams/kg/day'}], 'secondaryOutcomes': [{'measure': 'Feeding Tolerance', 'timeFrame': 'Daily for 28 days', 'description': 'Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume)'}, {'measure': 'Rate of Length and head circumference gain', 'timeFrame': 'weekly up to day 28', 'description': 'cm/week'}, {'measure': 'Total energy intake', 'timeFrame': '28 days', 'description': 'kcal'}, {'measure': 'Total protein intake', 'timeFrame': '28 days', 'description': 'grams'}, {'measure': 'Respiratory status', 'timeFrame': '28 days', 'description': 'Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation'}, {'measure': 'Incidence of NEC', 'timeFrame': 'Study Day 0 through 28', 'description': "Modified Bell's Staging Criteria"}, {'measure': 'Incidence of sepsis - clinical symptoms', 'timeFrame': 'Study Day 0 through 28', 'description': 'Clinical symptoms - Changes in respiration, blood pressure, body temperature, stool, blood sugar and heart rate'}, {'measure': 'Incidence of sepsis - culture for pathogens', 'timeFrame': 'Study day 0 through 28', 'description': 'Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant'}, {'measure': 'Incidence of sepsis - Antibiotic use', 'timeFrame': 'Study Day 0 through 28', 'description': 'Antibiotic use duration - less than 5 days ; 5 days or more'}, {'measure': 'Total serum CO2', 'timeFrame': 'Study days 0, 14, 28', 'description': 'less than 18 mmol/L'}, {'measure': 'Metabolic Acidosis', 'timeFrame': 'Study days 0, 14, 28', 'description': 'If CO2 \\<18 mmol/L then Blood gas; Acidity (pH), Carbon dioxide, partial pressure (pCO2; torr), Bicarbonate (mmol/L); Base Excess (mmol/L)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['VLBW - Very Low Birth Weight Infant']}, 'descriptionModule': {'briefSummary': 'A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '224 Days', 'minimumAge': '168 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinically and metabolically stable\n* Birth weight 700 g to less than or equal to 1,250 g\n* Appropriate birth weight for gestational age\n* 24 0/7 to 32 0/7 weeks' gestational age at birth\n* Exclusively fed human milk\n* Signed informed consent and authorization to use and/or disclose PHI\n\nExclusion Criteria:\n\n* Metabolic or chronic disease\n* 5-minute Apgar score \\<4\n* Major surgery\n* Ventilator dependent\n* Fluid restriction\n* Grade III or IV intraventricular hemorrhage (IVH)"}, 'identificationModule': {'nctId': 'NCT05744193', 'briefTitle': 'Feeding Study in VLBW Premature Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)', 'orgStudyIdInfo': {'id': '3394-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial Liquid Human Milk Fortifier', 'description': 'Liquid human milk fortifier to be added to human milk', 'interventionNames': ['Other: Exempt Infant Formula']}, {'type': 'EXPERIMENTAL', 'label': 'Liquid Human Milk Fortifier - Standard Protein', 'description': 'Liquid human milk fortifier to be added to human milk', 'interventionNames': ['Other: Exempt Infant Formula']}, {'type': 'EXPERIMENTAL', 'label': 'Liquid Human Milk Fortifier - High Protein', 'description': 'Liquid human milk fortifier to be added to human milk', 'interventionNames': ['Other: Exempt Infant Formula']}], 'interventions': [{'name': 'Exempt Infant Formula', 'type': 'OTHER', 'description': 'Liquid human milk fortifier to be added to human milk daily', 'armGroupLabels': ['Commercial Liquid Human Milk Fortifier', 'Liquid Human Milk Fortifier - High Protein', 'Liquid Human Milk Fortifier - Standard Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's Hospital", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Hospital, Long Island', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': "Cohen Children's Medical Center of NY", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}